Medtronic Neuromodulation 2023-11-08 Health serious FDA
Health · FDA · Recall #FDA-Z-0217-2024
LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device. Recall
Issued November 8, 2023 · Medtronic Neuromodulation
In November 2023, Medtronic Neuromodulation recalled the LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device., a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
There are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepancy in the Use By Date (UBD) printed on the outer packaged kit label versus the UBD printed on the individual product label.
What you should do
- 1 Stop using LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device. right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Medtronic Neuromodulation to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Medtronic Neuromodulation
- Category
- Health
- Recall date
- November 8, 2023
- Units affected
- Not reported
- Sold at
- US: MO, FL, TX, WA
- Recall number
- FDA-Z-0217-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Medtronic Neuromodulation has 5 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.